|
Device | RESTYLANE INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S028 |
Date Received | 09/22/2008 |
Decision Date | 10/22/2008 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO PERFORM A QUALITY CONTROL TEST IN-HOUSE THAT IS NOW BEING PERFORMED BY A CONTRACT LABORATORY. |